Episode 284

Design Assurance: The Unsung Heroes of R&D

Global Medical Device Podcast powered by Greenlight GuruOct 13, 2022 · 48 min

Episode Description

What is design assurance, and what function does it serve in the overall product design process? It’s not a role that gets a lot of upfront credit or name recognition, but it’s an important part of the process and impacts product development more than you may think at first.

Orla Connaughton joins the podcast today to discuss design assurance with Etienne Nichols. Orla began as a mechanical engineer and has a Master’s degree in Project Management. She has 18 years of experience, mostly working in the medical device sector, and has worked at a Senior Management level for both multi-national and start-up organizations. She’s been running her own company, Aztek Medical, for over 8 years. And she has a lot to say about design assurance.

Listen to the episode to hear the conversation as they discuss what’s involved in design assurance and why it’s so important. Orla shares how her thoughts on the scope of the design assurance process are related to The Lion King and how design assurance “packs the parachute” for the overall product design process.

Some of the highlights of this episode include:

Orla explains what’s involved in design assurance and why it’s required. Global regulations require that a product is developed in a specific way and that there’s evidence that the project is developed that way. A working prototype is a great thing to have, but it’s only a starting point.
Design assurance personnel have to be able to touch all the different processes and regulations. Orla explains that design assurance involves understanding the basic quality system standards and regulations, to product-specific standards, clinical investigations, and more.
There are no college programs that lead to a career as a design assurance professional. These positions want a technical background with a high level of understanding of many different types of products and roughly 5-10 years of relevant work experience in the area. The position also requires a level of creativity.
Although there’s no degree program leading to quality assurance, it’s often done as a module of a regulatory-type qualification, so it can be taught to people who are interested in learning the concepts.
Design assurance packs the parachute for the product design process by putting the pieces together in order to tell a cohesive story to the regulators that allow the device to get approved. People may not see design assurance up front, but they’re serving a vital function in the process.
Design assurance is a valuable process and skillset in its own right. It’s part of the big picture.

Memorable quotes from Orla Connaughton:

“Having a working, functioning prototype is great, and of course, it’s required, and it’s a great starting point, but really that is what it is – it’s a starting point.”

“Once you have a good technical solution, at that point, you should implement your design controls and start creating your documents and start releasing your procedures through this control process.

“What I really think makes a good design assurance specialist is the mindset element.”

“I think quite often creativity is not a trait that’s recognized with quality type professions, but really it’s very valuable in these situations.”

“The design assurance person is your quality engineer of the R&D process.”